Almac Clinical Technologies Announces Patient-Reported-Outcomes Partnership with FACIT.org
December 7, 2009
Almac announced today a unique partnership with FACIT.org for electronic distribution of the latter’s Patient-Reported-Outcomes (PRO) and Quality of Life (QOL) assessments. The partnership agreement empowers Almac to use and validate leading FACT and FACIT assessments through any and all electronic modalities including phone, web and handheld devices. As part of the agreement, Almac will also leverage the translation services that FACIT.org provides in delivering these instruments to patients worldwide.
FACIT questionnaires, including the notable Functional Assessment of Cancer Therapy-General (FACT-G), have been used in hundreds of clinical trials for oncology and other therapy areas and indications. The FACT-G (now in Version 4) is a compilation of general questions divided into four primary Quality of Life domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. It is used widely with any form of cancer, and has also been applied and validated in other chronic illness conditions, such as HIV/AIDS and multiple sclerosis.
With this new partnership Almac advances its goal of providing pharmaceutical and biotech companies with a world-class solution for Electronic-Patient-Reported-Outcomes (ePRO) using its patented IXR technology. Almac’s IXR platform seamlessly integrates various user interfaces in the collection and processing of clinical trial data. By utilizing its technology to deliver the FACT and FACIT assessments, Almac will significantly broaden the potential populations for these already widely-used patient assessments.
David Cella, Ph.D., President of Facit.org comments:
“We are excited about the potential of our relationship with Almac Clinical Technologies. Partnerships such as these help streamline the inclusion of valid patient-reported-outcome tools into clinical trials efficiently and accurately.”
Jim Murphy, President of Almac Clinical Technologies adds:
“The licensing agreement with FACIT.org allows Almac to further pursue our goal of delivering high quality ePRO data to sponsors by combining world-class patient assessments with state-of-the art technology that is user-friendly and eases the burdens of patients in clinical trials.”
The FACIT.org agreement is one piece of an evolving Almac strategy that focuses on improving the patient’s experience in clinical trials. It is Almac’s belief that reaching out to patients in the most convenient manner by utilizing the most user-friendly tools available will help in patient recruitment, retention and compliance in clinical trials, allowing more successful and longer term relationships to develop between biopharmaceutical companies and the patient community.
Dr. Joseph Bedford, Director of Marketing at Almac Clinical Technologies notes: “Almac understands that two of the greatest challenges in clinical trials are recruiting/retaining patients and generating high quality data for regulatory submission. The FACIT.org partnership helps us address both challenges by giving Almac access to some of the most notable scales used to gather PRO data and collecting it in a secure, user-friendly way that assures data integrity and quality for our clients.”
FACIT.org manages the distribution and information regarding administration, scoring and interpretation of the FACIT system of questionnaires used for measuring health-related quality of life for people with chronic illnesses. While oncology remains a major focus of the FACIT system of questionnaires, the organization has also developed and translated instruments for fatigue, treatment satisfaction, spiritual well-being, HIV disease, multiple sclerosis, and other chronic conditions. This accumulated work has produced over 750 unique questions in more than 60 languages that are routinely used in clinical trials and for other purposes. FACIT.org’s mission is to promote the use and application of these measurements as a means of improving healthcare for chronic illnesses worldwide.
About Almac Clinical Technologies:
Almac Clinical Technologies is a division of the Almac Group that specializes in interactive technology and service solutions to increase the quality and efficiency of the clinical trial process. Our solutions include Interactive Voice and Web Response Systems (IXRS™) for patient randomization, tracking and clinical supply management; electronic patient reported outcomes data collection; and Web drug reconciliation. Almac’s technologies have been deployed in over 1400 clinical trials, incorporating over 1.5 million patients in over 80 countries and more than 60 languages.
About Almac Group:
The Almac Group comprises five closely integrated divisions offering a broad range of services from R&D, translational genomic services, API manufacture, formulation development, clinical trial supply and technology (IVRS & Web), to commercial-scale manufacture. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors.
The company employs over 2,500 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. Construction of the company’s new $120m North American Headquarters started in July 08 and is expected to be completed 2010. Almac was awarded Northern Ireland’s “Business of the Year” award in 2009.
For more information about the Almac Group, please visit www.almacgroup.com or e-mail [email protected].
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